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REGULATORY UPDATE: FDA Issues Draft Guidance to Support CGT Development

November 19, 2024

The Food and Drug Administration released a new draft guidance for industry on Monday intended to help facilitate the development of safe, effective and high-quality cellular and gene therapy (CGT) products. 

The document addresses frequently asked questions (FAQs) and common challenges encountered during CGT product development. The FAQs span several key disciplines:

  • Regulatory review.
  • Chemistry, manufacturing and controls.
  • Pharmacology/toxicology.
  • Clinical pharmacology. 

The guidance reflects FDA’s current thinking and provides recommendations rather than enforceable requirements, except where specific regulatory or statutory mandates apply. FDA plans to add more FAQs to the guidance as needed.

The agency is accepting comments on the draft guidance through Feb. 18. The Federal Register notice provides additional instructions. AABB also encourages members to share feedback with the Association via email.